METOPROLOL TARTRATE- metoprolol tartrate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets, USP are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets, USP therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS , and WARNINGS ). Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hyperse

Product summary:

Metoprolol Tartrate Tablets, USP are available as follows:   Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side. Bottles of 30            NDC 68788-6907-3 (Child Resistant Closure) Bottles of 60            NDC 68788-6907-6 (Child Resistant Closure) Bottles of 90            NDC 68788-6907-9 (Child Resistant Closure) Bottles of 100            NDC 68788-6907-1 (Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch    Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: 04/2018 Repackaged By: Preferred Pharmaceuticals Inc

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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METOPROLOL TARTRATE TABLETS, USP
RX ONLY
DESCRIPTION
Metoprolol tartrate USP is a selective beta -adrenoreceptor blocking
agent, available as 25, 50 and 100
mg tablets for oral administration. Metoprolol tartrate is
(±)-1-(isopropylamino)-3-[_p_-(2-
methoxyethyl)phenoxy]-2-propanol (2:1) _dextro_-tartrate salt. Its
structural formula is:
Metoprolol tartrate USP is a white, practically odorless, crystalline
powder with a molecular weight of
684.82. It is very soluble in water; freely soluble in methylene
chloride, in chloroform, and in alcohol;
slightly soluble in acetone; and insoluble in ether.
Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of
metoprolol tartrate.
The tablets contain the following inactive ingredients:
microcrystalline cellulose, corn starch, sodium
starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate,
talc, magnesium stearate,
hypromellose, titanium dioxide, polyethylene glycol and polysorbate
80. In addition, 50 mg tablet
contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C
Blue #2 Aluminium Lake as
coloring agents.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol tartrate is a beta -selective (cardioselective) adrenergic
receptor blocker. This preferential
effect is not absolute, however, and at higher plasma concentrations,
metoprolol also inhibits beta -
adrenoreceptors, chiefly located in the bronchial and vascular
musculature.
Clinical pharmacology studies have demonstrated the beta-blocking
activity of metoprolol, as shown by
(1) reduction in heart rate and cardiac output at rest and upon
exercise, (2) reduction of systolic blood
pressure upon exercise, (3) inhibition of isoproterenol-induced
tachycardia, and (4) reduction of reflex
orthostatic tachycardia.
_HYPERTENSION_
The mechanism of the antihypertensive effects of beta-blocking agents
has not been fully elucidated.
However, several possible mechanisms have been proposed: (1)